BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    LUNG TECHNOLOGIES 5000 THERAPEUTIC INCENTIVE SPIROMETER

    K Number: K944344 · Decision Feb 3, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    107
    Applicant Total
    1
    Review Days
    150

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    Basic Information

    Device Name
    LUNG TECHNOLOGIES 5000 THERAPEUTIC INCENTIVE SPIROMETER
    K Number
    K944344
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5690
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Lung Technologies, Inc.
    Date Received
    September 6, 1994
    Decision Date
    February 3, 1995
    Product Code
    BWF
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    BWF Spirometer, Therapeutic (Incentive)

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